Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT01174992
Eligibility Criteria:
Inclusion Criteria:
* Patient undergoing elective craniotomy/craniectomy
* Age greater than or equal to 18 years
* Patients who are able and willing to comply with the procedures required by the protocol.
* Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures.
Exclusion Criteria:
* Chemotherapy or radiation therapy within 7 days following surgery.
* Conditions compromising the immune system.
* Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product.
* Female subjects of childbearing potential with a positive pregnancy test prior to surgery.
* Female subjects who are breastfeeding or intend to become pregnant during the clinical study period.
* Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment.
* Major intraoperative findings or complications identified by the surgeon that may preclude conduct of the planned surgical procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01174992
Study Brief:
Protocol Section:
NCT01174992